Japan drug development regulations

With the enforcement of the revised PAL and relevant regulations, ICH harmonization and globalization of drug development will bring a new era for drug development and reviewing system of NDAs so that Japan will become a full member of the countries in the long run. 

In 1993 Witte et al. [28] and in 1994 Rauws and Groen [29] reviewed the status of the regulation of chiral medicinal products on the pharmaceutical industries in the United States, Japan, and some European countries where designated authorities are responsible for the control and approval of newly developed drugs (both chiral and nonchiral). In the United States, new drug applications are submitted to the Food and Drug Administration (FDA), which requires appro-... 

USA, and Japan since 1990. This effort is supported by the pharmaceutical companies because it will make for more efficient regulation in the most attractive markets and will also be beneficial to patients with faster availability of new drugs. The ICH aims to eliminate duplication of assays during research and development of new drugs, as well as provide guidelines intended to unify the requirements for approval (Walsh, 2004a Foulkes and Traynor, 1999). 

The development of regulations governing drug safety studies around the world has generally followed the development of regulations in the U.S. Such regulations were promulgated in the EEC in 1980, in Canada in 1981, and in Japan in 1984. 

The United States Food and Drug Administration (FDA) has endorsed the guidance prepared under the auspices of the International Conference on Flarmonisation of Technical Requirements for Registration of Pharmaceuticals for Fluman Use (ICH). The guidance, developed through the joint efforts of regulators and industry representatives from the European Union, Japan, and the United States, helps ensure that the different regions have consistent requirements for the data that should be submitted to the various... 

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